228 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·June 16, 2021
Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL 36832 Product Usage: IVD for drugs of abuse
FDA Recall
Terminated
·Capitol Vial Inc·Product code JKA·October 7, 2011
DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code JDI·May 7, 2021
GENICON EZEE Retrieval, sterile, Rx only.
FDA Recall
Terminated
·Genicon, Inc.·Product code GCJ·July 19, 2017
GENICON EZEE Retrieval, sterile, Rx only.
FDA Enforcement
Class II
·Terminated·Genicon, Inc.·March 28, 2018
First Aid Only brand cabinets (typically metal wall mount) containing ibuprofen tablets and a variety of other first aid supplies: Item 249-0/FAO Item 249-0/P Item 249-RK/P First Aid Exchange brand cabinet: Item 1300-FAE-0103 Item 1300-FAE-0108 and Item 1300-PAT-0109
FDA Recall
Terminated
·First Aid Only Inc·Product code LRR·December 10, 2007
Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 *** Catheter Length: 571 mm *** STERILE ***.
FDA Recall
Terminated
·Sorenson Medical, Inc.·Product code BSY·November 25, 2002
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid, PN 7450; Indicated for relining a denture surface.
FDA Enforcement
Class II
·Terminated·CMP Industries, Llc·July 6, 2016
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.·August 12, 2015
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306 4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450, 5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465 Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base
FDA Enforcement
Class II
·Terminated·CMP Industries, Llc·July 6, 2016
NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch, disposable electrode. System is manufactured by AngioDynamics, Inc. --- Catalog #20300101 Intended use: the generator system with six outputs is indicated for surgical ablation of soft tissue.
FDA Recall
Terminated
·Angiodynamics Worldwide Headquarters·Product code OAB·January 20, 2012
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid, PN 7450; Indicated for relining a denture surface.
FDA Recall
Terminated
·CMP Industries, Llc·Product code EBI·April 28, 2016
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JJE·March 30, 2016
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306 4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450, 5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465 Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base
FDA Recall
Terminated
·CMP Industries, Llc·Product code EBI·March 2, 2016
Ibuprofen tablet refills in cardboard boxes or clear plastic bags for first aid kits and cabinets First Aid Only, Inc., Vancouver, WA. Ibuprofen Tablets, Item A405-WIP, Item A405-10 Ibuprofen Tablets, Item FAE-7014;; Ibuprofen Tablets, Item H430; Ibuprofen Tablets, Item I431; Ibuprofen Tablets, item J432 and Ibuprofen Tablets, item Z6100
FDA Recall
Terminated
·First Aid Only Inc·Product code GAA41·December 10, 2007
EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.
FDA Enforcement
Class II
·Terminated·Molnlycke Health Care, Inc·May 8, 2019
Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System US Only: 1050-110-ENG Outside US: 1050-110-ENG, I050-240-XXX (generic), 1050-240-ENG, 1050-240-SPN, 1050-240-ITL, 1050-240GER, 1050-240-DUT, 1050-240-FRN, 1050-240-CZE, 1050-IIO-JPN. Provides perioperative autotransfusion ( salvaging and reinfusing red blood cells (RBC's) from blood shed from patients undergoing orthopedic surgery. The portable system is used in operating rooms to recycle blood lost during surgery and in the recovery room to recycle blood lost after surgery. It can be transported to the patient floor for postoperative salvage.
FDA Recall
Terminated
·Haemonetics Corporation·Product code CAC·April 29, 2011
SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300 The SCREENERS Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at a given cutoff concentrations (refer to PN: 42131-SC). The SCREENERS Dip Drug Test is used to obtain a visual, qualitative result and is intended for professional use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation meth Drugs covered by the Screeners Dip Drug Test (SCD-7MB300): BAR, BZO, COC, MET, OPI300, PCP, THC.
FDA Recall
Terminated
·Ameditech Inc 10340 Camino Santa Fe·Product code DKZ·April 26, 2011
ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived Product Usage: The ProScreen Drugs of Abuse Test Cup is a one-step immunoassay for the qualitative detection of multiple drugs in human urine (refer to PN: 42141-PS-W). The ProScreen Drugs of Abuse Test Cup is used to obtain a visual, qualitative result and is intended for professional use only. The ProScreen Drugs of Abuse Cup is not for legal or medical diagnostic purposes. This device is not intended for workplace testing. For diagnostic and treatment purposes, consult with a healthcare or substance abuse professional. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.
FDA Recall
Terminated
·Ameditech Inc 10340 Camino Santa Fe·Product code DKZ·June 7, 2011